A randomised double blind trial of add-on flunarizine to prevent the cognitive deterioration associated with infantile spasms
| ISRCTN | ISRCTN36757519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36757519 |
| Secondary identifying numbers | MCT-53573 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 08/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lionel Carmant
Scientific
Scientific
Service de Neurologie
Hôpital Sainte-Justine
3175 Chemin de la Côte Ste-Catherine
Montréal, Quebec
H3T 1C5
Canada
| Phone | +1 514 345 4931 (6106) |
|---|---|
| lionel.carmant@umontreal.ca |
Study information
| Study design | Randomised double blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To determine whether infants and children receiving the Infantile Spasms (IS) standard therapy as well as Flunarizine will have an improved developmental outcome as compared to that of children receiving the same treatment with a placebo. |
| Ethics approval(s) | Ethics approval received from the Hôpital Sainte-Justine, Comité d'éthique de la recherche on the 15th July 2004. |
| Health condition(s) or problem(s) studied | Infantile Spasms (IS) |
| Intervention | All infants and children will receive initial IS conventional therapy, consisting of Vigabatrin (VGB) administration (as well as vitamin B6), followed after a two week period by Adrenocorticotropic Hormone (ACTH - Synacthen) treatment, if no IS cessation or amelioration occurs. Moreover, if the infants or children's' IS still do not respond to the latter hormone, they may be treated with Topiramate. Besides the standard IS treatment, Flunarizine or placebo will be administered from the onset of the study for a total of six months in order to determine its efficacy in preventing or ameliorating the mental deterioration associated with IS. After this time, all treatment will be ceased. Following cessation of treatment, the neurological and neuro-psychological status of infants and children will still be followed for an additional one and one half year period to determine their long-term response to Flunarizine (and to placebo) and to assess their mental development. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Flunarizine, vigabatrin, synacthen, topiramate |
| Primary outcome measure | Intelligence Quotient (IQ) scores are evaluated with Bayley scales at time 0 and 24 months. |
| Secondary outcome measures | 1. Autistic behaviour 2. Longitudinal development and pattern of developmental progress in infants and children 3. Occurrence of IS |
| Overall study start date | 01/04/2002 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 18 Months |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Children aged 3 - 18 months, either sex, with new onset infantile spasms 2. Electroencephalogram (EEG) showing hypsarrhythmia or modified hypsarrhythmia 3. Children not receiving treatment for infantile spasms at the time of the initial visit, i.e. vigabatrin or synacthen 4. Parents or legal guardian agree to sign the consent form |
| Key exclusion criteria | 1. Age under 3 months or over 18 months at onset of spasms 2. Degenerative neurological disorder because their relentless course toward a poor outcome regardless of therapeutic interventions would limit the possibility of generalising our findings to all children with infantile spasms 3. Pre-existing medical condition where steroids would be contraindicated 4. Families unable to comply with follow-up visits or agree to informed consent |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Service de Neurologie
Montréal, Quebec
H3T 1C5
Canada
H3T 1C5
Canada
Sponsor information
Hôpital Sainte-Justine (Montréal) (Canada)
Not defined
Not defined
3175 chemin Côte Ste-Catherine
Montréal, Quebec
H3T 1C5
Canada
"ROR" |
https://ror.org/01gv74p78 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53573)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
